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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported from an anonymous survey result that the fusion rate observed at the 12 month follow up after use of altapore for implantation in place of cortico-cancellous or cancellous allograft or autograft bone in low load or compression environments for plastic/reconstructive surgery procedures was 51-60%.The physician reported "tibia fractures, facial fractures sometimes have ended up requiring supplemental autologous bone grafting after failure to achieve union with traditional approach.Usually in setting of osteomyelitis¿.At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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Search Alerts/Recalls
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